FIRESTONES : Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser: a Randomized Controlled Two-parallel Group Multicenter Trial With Blinding Evaluation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 374
- 试验地点
- 9
- 主要终点
- Rate of stone free patients
研究概览
简要总结
In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.
详细描述
Flexible ureteroscopy is the most common technique to treat kidney stones and is the treatment of choice in France.
Kidney stones destruction requires its laser pulverization into small fragments in order to remove them through the ureter or improve their spontaneous expulsion along the urinary tract. However, most of the time, all the micro-fragments and dust created during stone destruction cannot be extracted using our surgical tools, and may stay intra-renally at the end of the procedure. Although these micro-fragments are expected to disappear spontaneously by the natural flushing and peristalsis of the upper urinary tract, they remain at risk of stagnation that could be the nest of new aggregation and stone formation.
Adjuvant treatments (such as forced diuresis, inversion or mechanical pressure) were previously described to improve the expulsion of stone fragments after extra-corporeal shock wave lithotripsy.
Nevertheless, the impact of adjuvant treatment after flexible ureteroscopy remains unclear and mainly theoretical.
In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will not be blinded except for the outcome assessment: radiologists in charge of interpreting CT-Scans will be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old and < 80 years old
- •With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
- •Participants covered by or entitled to social security
- •Written informed consent obtained from the participant
- •Ability for participant to comply with the requirements of the study
排除标准
- •Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship)
- •Contra-indication to Furosemide:
- •Hyper-sensitivity to the active substance or one of the excipients
- •Hyper-sensitivity to Sulfonamide
- •Renal failure with oligo-anuria refractory to Furosemide
- •Hypokalemia < 3,5 mmol/L
- •Severe hyponatremia
- •Hypovolemia with or without hypotension or dehydration
- •Ongoing hepatitis, hepatic insufficiency severe and hepatic encephalopathy
- •Patient having Furosemide as usual treatment
- •Patient requiring an injection of Aminoside or Vancomycin before or during the procedure
- •Participation in other interventional research with an investigational drug or medical device
研究组 & 干预措施
Furosemide
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
干预措施: Furosemide 40 mg (Drug)
结局指标
主要结局
Rate of stone free patients
时间窗: At 3 months
Rate of stone-free patients 3 months after a flexible ureteroscopy for renal stone laser destruction, evaluated on the low dose abdomino-pelvic CT-Scan. A centralized review of the images will be performed by two specialized radiologists, in a blind and crossed way to allow a homogenization of the results
次要结局
- Opioid consumption(During the hospital stay, an average of 1 day)
- Pain in a scale(During the hospital stay)
- Rate of urinary infection(From baseline to 30 days)
- Number of participants with adverse events(From baseline to 3 months, an average of 1 day)